On November 8, 2022 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported poster presentations of pre-clinical data and trial-in-progress for the ongoing ITIL-306 Phase 1 clinical trial using the CoStimulatory Antigen Receptor (CoStAR) platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), to be held from November 8-12, 2022 (Press release, Instil Bio, NOV 8, 2022, View Source [SID1234623427]).

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Pre-clinical data demonstrating the activity of CoStAR across physiologically-relevant ranges of FRα expression and TCR affinity are featured in Poster 282. These data demonstrated that CoStAR amplified T-cell responses at all FRα expression levels as long as FRα was expressed, supporting the clinical exploration of ITIL-306 in multiple solid tumor types with a variety of FRα expression levels. Furthermore, CoStAR-expressing cells do not respond to FRα in the absence of TCR stimulation, underscoring the expected safety profile of the CoStAR platform. Currently, ITIL-306 is being evaluated in a first-in-human Phase 1 dose escalation clinical study for treatment of refractory solid tumors with the first patient dosed in October 2022.

The company also is presenting a trial-in-progress poster summarizing the design of the ongoing Phase 1 study of ITIL-306 (Poster 776). ITIL-306-201 is a Phase 1 multicenter, single-arm, dose escalation and expansion study evaluating the safety and feasibility of ITIL-306 in adult patients with advanced epithelial ovarian cancer (EOC), non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) who relapsed from or are refractory to ≥1 prior line of systemic therapy. Importantly, the Phase 1 study of ITIL-306 features a treatment regimen free of high-dose interleukin-2.

Details of the poster presentations are as follows:

Title: Anti-folate receptor alpha (FRα) CoStimulatory Antigen Receptor (CoStAR) improves T-cell function across physiologically relevant ranges of FRα expression and T-cell receptor (TCR) affinities
Authors: Martina Sykorova, Michelle Mojadidi, Leyuan Bao, Eric Gschweng, Milena Kalaitsidou, Gray Kueberuwa, Xingliang (Tim) Zhou, Rubén Alvarez-Rodríguez, John S. Bridgeman
Poster/Abstract Number: 282

Title: ITIL-306-201: A multicenter, first-in-human phase 1a/1b study of ITIL-306, an engineered autologous tumor-infiltrating lymphocyte (TIL) cell therapy product, in adults with advanced solid tumors
Authors: Jeffrey Ward, Armin Ghobadi, John B. Liao, Adam Schoenfeld, Scott S. Tykodi, Yizhou Jiang, John Le Gall, Ruben Alvarez-Rodriguez, Marika Sherman, Tiffany Singson, Jeff McLeroy
Poster/Abstract Number: 776

The posters are available on the publications section of the Instil Bio website: www.instilbio.com/publications.